Experience

EmitBio Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Scientific Officer

  • May 2020 - Mar 2022

  Durham, North Carolina, United States



Novan, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• President and Chief Scientific Officer

  • Jun 2017 - Jan 2019

  Research Triangle, NC Novan, Inc. is a clinical-stage biotechnology company focused on leveraging nitric oxide’s natural antiviral and immunomodulatory mechanisms of action to treat dermatological and oncovirus-mediated diseases. We believe that our ability to conveniently deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to significantly improve patient outcomes in a variety of diseases.

• President and Chief Executive Officer, Co-Founder

  • Jan 2008 - Jun 2017

  Led or participated in the execution of >90 nonclinical studies across the translational science spectrum including in vitro/in vivo pharmacology studies to support target engagement as well as in vitro/in vivo toxicology studies from from IND through NDA. Led the federal grant and contract research program totaling 12 federal awards (NIH, NSF, DOD, BARDA) with a 52% success rate totaling north of $15M in awarded funding. Served as the Principle Investigator on 10 of the 12… Show more Led or participated in the execution of >90 nonclinical studies across the translational science spectrum including in vitro/in vivo pharmacology studies to support target engagement as well as in vitro/in vivo toxicology studies from from IND through NDA. Led the federal grant and contract research program totaling 12 federal awards (NIH, NSF, DOD, BARDA) with a 52% success rate totaling north of $15M in awarded funding. Served as the Principle Investigator on 10 of the 12 successfully awarded projects. Successfully scaled NCE technology from academic bench top to commercial scale as an integral part of the process chemistry, process development, and engineering team. Oversight of all functions of CMC development including drug substance, drug product, and analytical testing from IND to EOP2. Developed a collaborative approach with the agency for a macromolecular drug delivery technology that incorporates critical quality attributes from a blend of regulatory guidance documents. Key participant in the drafting of pre-meeting materials and attendee at formal meetings with the FDA including pre-IND, EOP2, and pre-NDA type B meetings. In partnership with the Chief Medical Officer or Chief Development Officer, directed the clinical development program which encompassed numerous Phase 1 studies and five successful Phase 2 studies across 4 indications with diverse modes of action and included clinical testing of three proprietary nitric oxide product formulations. As a co-Inventor and in combination with the Vice President of Intellectual Capital, developed a robust IP portfolio that included over 100 patent and applications prosecuted both domestically and in international major markets. Led the teamwide effort to maximize shareholder value pre-IPO in therapeutic indications outside the field of dermatology which resulted in the creation of a wholly owned subsidiary, KnowBio, LLC which was subsequently spun-out as a private entity pre-IPO in 2015.



KNOW Bio

• Board Member

  • Jan 2016 - Sep 2018

  Research Triangle, NC KNOW Bio, LLC was created in late 2015 from the separation of all non-dermatological assets from Novan, Inc (NASDAQ: NOVN) as part of the entrepreneurial vision to develop and optimize a proprietary nitric oxide platform from Co-Founders Dr. Mark Schoenfisch and Dr. Nathan Stasko. The core suite of chemistries enable the delivery of nitric oxide as a drug in a variety of doses and release time frames, which makes the therapeutic areas that will likely be impacted by this platform immense.… Show more KNOW Bio, LLC was created in late 2015 from the separation of all non-dermatological assets from Novan, Inc (NASDAQ: NOVN) as part of the entrepreneurial vision to develop and optimize a proprietary nitric oxide platform from Co-Founders Dr. Mark Schoenfisch and Dr. Nathan Stasko. The core suite of chemistries enable the delivery of nitric oxide as a drug in a variety of doses and release time frames, which makes the therapeutic areas that will likely be impacted by this platform immense. Founding Investor of Novan, Inc, Neal Hunter, now leads KnowBio,LLC as Managing Director and Chairman of its Board of Managers. Show less